Canada-based medical device company Traferox Technologies has received US Food and Drug Administration (FDA) 510(k) clearance for the X°Port Heart Preservation System, a device designed to enable static 10°C heart preservation during transport prior to transplantation.
According to the company, the system is indicated for the static hypothermic preservation of donor hearts at 4°C to 10°C for up to four hours using a del Nido or equivalent cold storage solution.
Following the FDA clearance, Traferox will begin making 10°C heart preservation available to transplant centres across the United States.
Traferox CEO Rick Mangat said, “The strong clinical evidence supporting 10°C heart preservation, together with the successful adoption of 10°C preservation across leading lung transplant programs, has demonstrated the potential of this approach to improve donor organ preservation and transport.”
Mangat added that Traferox will work with transplant centres across the US to support the continued adoption of 10°C preservation in routine clinical practice.
The clearance comes as clinical evidence supporting 10°C heart preservation continues to grow. Published, peer-reviewed studies have associated 10°C heart preservation with improved early outcomes, including reductions in severe primary graft dysfunction and improved post-transplant survival compared with conventional ice storage and other hypothermic temperatures. These findings have also been reported in transplants involving higher-risk donor hearts.
Vanderbilt University Medical Center was the first US institution to clinically investigate 10°C heart preservation, building on the success of 10°C preservation in lung transplantation. As the largest heart transplant centre in the US, Vanderbilt has since completed more than 150 procurements using 10°C preservation and reported improved outcomes despite the use of higher-risk donor hearts.
“10°C preservation has changed how we approach donor heart preservation. It is the standard in our institution for performing heart transplantation,” said Dr Ashish Shah, Surgical Director of Vanderbilt’s heart transplant programme.
According to Traferox, X°Port Heart builds on the company’s US commercial launch of X°Port Lung in Q3 2025.
Joe Kletzel, President of Traferox, said, “With X°Port Heart, we are expanding that commitment to heart transplantation while building on the strong foundation established with the market leading X°Port Lung Preservation System and the newly launched TorEx Lung Perfusion System. Together, these technologies reflect our broader vision to provide transplant programs with clinically meaningful, practical solutions across the continuum of organ preservation.”
